Tuesday, 28 December 2010

T 1450/07 – Plausible Function

The requirement of industrial applicability is not a very stringent one. Objections of non compliance with A 57 are rare, and hardly ever successful … except in the domain of biotechnology, where applicants are sometimes tempted to try to protect polynucleotides before knowing what they could be used for.

Claim 1 on file read :

1. A polynucleotide selected from the group consisting of
(a) polynucleotides encoding a polypeptide comprising the amino acid sequence as shown in Seq.ID No.2;
(b) polynucleotides encoding a polypeptide comprising the amino acid sequence from residues 1 to 329 as depicted in Seq.ID No.2;
(c) an allelic variant of the polynucleotide of (a) or (b);
or the complementary strand of such a polynucleotide.

Having dealt with A 123(2) and A 56, the Board has to answer the question of whether this claim fulfils the requirements of A 57.

[5] The existing case law establishes the criteria to be fulfilled for industrial applicability to be acknowledged (see e.g. T 898/05). The information in the application as filed should make plausible the identity of the claimed compound. Thus, the compound may be attributed to a known family of molecules on the basis of a comparison between its primary structure and that of molecules known in the art. Then, its putative functions must be disclosed. Experimental evidence is not necessarily needed. A number of reasonable assumptions may be made by taking into account the known functions of other family members as well as, for example and not exclusively, by taking into account the distribution of the claimed compound in the body. It should also be clear that the treatments therein mentioned are in relation to the function plausibly attributed to the molecule. Post-published evidence backing up these assumptions is always welcome. In fact, the more information, the better and the quality of the information is also fundamental. As often repeated, each case must be evaluated on its own merit.

[6] The present application identifies TGFα-HII as a member of the EGF/TGF family of transforming growth factors on the basis that it comprises a domain with six cysteine residues characteristic of that family and exhibits a degree of identity of 26% and a degree of similarity of 46% with the first isolated TGFα molecule - over a 236 amino acid stretch […]. These are the features previously used in the art as characterizing features of EGF/TGF family members even if the percentages of homology, 33% in case of mouse, rat TGF and murine EGF […], or of similarity, 50% between betacellulin and rat TGFα […] are somewhat different. In the board's judgment, this comparison makes it plausible that TGFα-HII is indeed a member of the EGF/TGF family.

[7] As regards the properties of TGFα-HII itself, it is mentioned on page 6, lines 7 to 9, that:
“A polynucleotide encoding a polypeptide of the present invention may be obtained from human brain and early stage brain tissue.”
Its putative functions and the therapeutic benefits to be drawn therefrom have been defined essentially as those earlier established for members of the EGF/TGF family.

For example, it is mentioned […] that:
“There appears to be a widespread distribution of TGFα in various regions of the brain ... Accordingly, in instances where neurological functioning is diminished, an administration of the polypeptide of the present invention may stimulate the brain and enhance proper physiological function.” and,
“TGFα-HII or soluble form thereof may also be employed to treat ocular disorders, for example, corneal inflammation. A variety of experiments have implicated members of the TGFα gene family in such pathologies.” and,
“Treatment may also be related to liver regeneration or liver disfunction, since TGFα and its homologs and hepatocyte growth factor trigger hepatocyte regeneration after partial hepatectomy and after acute cell liver necrosis...”.
[8] Several post-published documents have been cited which experimentally confirm the information provided by the patent application.

Document D15 […] shows that a protein with the same sequence as TGFα-HII, namely TAT137 is over-expressed in prostate cancer. In document D20 […], it is described that an anti- TGFα-HII (identified as TMEFF2) monoclonal antibody conjugated to the cytotoxic agent auristatin E was used with success to treat immunodeficient mice bearing xenografted prostate cancers. Document D4 reports that TMEFF2 is widely expressed in the brain and that a fragment consisting of the extracellular domain of TMEFF2 increases survival of neurons. […] The authors conclude that:
“These findings indicate that TMEFF2 holds promise as a candidate for use in the treatment of neurodegenerative disorders such as Parkinson's disease.”
[9] There is no doubt that the properties attributed to TGFα-HII make it suitable for use in the pharmaceutical industry.

[10] In accordance with the above mentioned case law and taking into account the sum total of this information, it is decided that the requirement of industrial applicability is fulfilled.

Should you wish to download the whole decision, just click here.

To have a look at the file wrapper, click here.

A related decision can be found here.